MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK 6F 071 DELIVERY CATHETER; DQY

Model Number	BMK6F95BER120
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the benchmark was fractured approximately 2.5 cm from the hub.The benchmark was kinked approximately 45.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed that the catheter was fractured.If the benchmark is forcefully advanced against resistance or is otherwise manipulated at extreme angles during use, damage such as a kink and subsequent fracture may occur.Further evaluation of the returned benchmark revealed a kink in the catheter shaft.This damage was likely incidental to the reported complaint.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician advanced the benchmark into the patient and subsequently, the benchmark would not advance through the patient¿s anatomy.Therefore, the physician decided to remove the benchmark.Upon removal, it was noticed that the benchmark was broken and unraveled.The procedure was completed using a non-penumbra guide sheath.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11217850
• Report Number: 3005168196-2021-00149
• Device Sequence Number: 3861637
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F99418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005